The US Food and Drug Administration (FDA) has granted OncoSil Medical a Humanitarian Device Exemption (HDE) for its OncoSil device to treat distal cholangiocarcinoma (dCCA), a rare and aggressive form of bile duct cancer.

The OncoSil device delivers targeted beta radiation directly into tumours through an injection, aiming to destroy cancer cells while minimising damage to surrounding healthy tissue. The US approval follows the device’s European clearance in 2020 for patients with locally advanced pancreatic cancer.

According to the Cholangiocarcinoma Foundation, around 10,000 people in the US are diagnosed with dCCA each year. The disease is often detected at an advanced stage because it can develop with few early symptoms. 

Patients face poor outcomes, with median overall survival reported to be as low as 6.7 months. Current treatment options, including palliative stenting, chemotherapy and conventional radiation, have limited effectiveness in advanced disease.

Initially, the OncoSil device will be available at up to five US treatment centres under the conditions of the HDE. The centres will be required to have appropriately trained healthcare professionals and participate in an FDA-mandated post-approval study (PAS).

The multicentre, prospective PAS will assess the safety and potential clinical benefit of the device in adults aged 21 and above with unresectable, non-metastatic dCCA. The study is expected to enrol 30 patients, who will be followed for up to 24 months. OncoSil said the final study protocol and associated requirements will be agreed with the FDA.

The Australian medical technology company expects to launch the OncoSil device in the US in Q2 FY2027.

OncoSil Medical CEO Nigel Lange described the FDA decision as a major milestone for the company, saying it creates a pathway to make the technology available to US patients with dCCA, where significant unmet clinical need remains.

The company will now focus on establishing treatment centres, working with leading cancer institutions and clinical teams, advancing reimbursement and market access, and supporting the long-term adoption of the technology in the US.